EUCTR2014-001546-25-NL
Active, not recruiting
Phase 1
Short versus extended antibiotic treatment with a carbapenem for high-risk febrile neutropenia in hematology patients with Fever of Unknown Origin: a randomized multicenter open-label non-inferiority trial. - SHORT-trial
VU University Medical Center0 sites240 target enrollmentNovember 19, 2014
ConditionsFebrile neutropeniaMedDRA version: 19.1Level: PTClassification code 10063581Term: Stem cell transplantSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 19.1Level: LLTClassification code 10002969Term: Aplastic anemiaSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 19.1Level: LLTClassification code 10003999Term: BacteremiaSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 19.1Level: LLTClassification code 10007810Term: Catheter related infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 19.1Level: LLTClassification code 10028566Term: MyelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: LLTClassification code 10062957Term: Catheter bacteraemiaSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 19.1Level: PTClassification code 10025310Term: LymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: LLTClassification code 10024329Term: LeukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: PTClassification code 10056520Term: Catheter site infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 19.1Level: PTClassification code 10016288Term: Febrile neutropeniaSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Febrile neutropenia
- Sponsor
- VU University Medical Center
- Enrollment
- 240
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Patients with malignant hematological diseases being treated with cytotoxic chemotherapy or stem cell transplantation;
- •2\.High\-risk neutropenia;
- •4\.Age 18 years or older;
- •5\.Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 220
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 20
Exclusion Criteria
- •1\.Contraindications to use of imipenem\-cilastatin or meropenem such as allergy, previous severe side\-effects or previous microbiological cultures with carbapenem\-resistant microorganism(s).
- •2\.Corticosteroid use \=10 mg per day prednisolone or equivalent for more than 3 consecutive days during the previous 7 days.
- •3\.Clinically or microbiologically documented infection.
- •4\.Symptoms of septic shock (systolic blood pressure \<90 mm Hg unresponsive to fluid resuscitation and/or oliguria (urine production \<500mL/day).
- •5\.Previous enrollment in this study during the same episode of neutropenia.
- •6\.Any critical illness for which Intensive Care Unit treatment is required.
- •7\.Legal incompetency
Outcomes
Primary Outcomes
Not specified
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